...consent is the procedure of getting permission to take part in a research study or medical procedure founded on access to all vital and easily understandable information about the consequences of participation in terms of benefits and harms (Dolgoff et al, 2009). A healthcare provider may demand informed consent from a patient before providing care or a researcher may request it from a participant before enrolling the individual into a research trial. Informed consent is based on guidelines provided by research and medical ethics. To give informed consent, the person involved must have sufficient reasoning faculties and have all the relevant facts. However, not all individuals may have capacities for informed consent due to impairments to reasoning and judgment such as mental immaturity, severe intellectual disabilities, mental illnesses, high stress levels, being in a coma, Alzheimer’s disease, and severe sleep deprivation. Medical and research actions may be carried out due to lack of informed consent. When a person is considered unable to give informed consent, another person can be authorized to give consent on behalf of that person (Manson & O'Neill, 2007). For instance, legal guardians or parents may give informed consent for young children and the mentally ill. In case a person is given insufficient information to make a reasoned decision, severe ethical issues may arise. In clinical trials, such cases are anticipated and avoided by Institutional Review Boards or ethics...
Words: 2720 - Pages: 11
...patient has the legal right to be informed and knowledgeable concerning any procedure performed by all medical personnel. The fact that an emergency situation has occurred does not change those rights. Being in a vulnerable state of mind when facing an emergency situation can be scary enough without facing the situation uninformed and unknowledgeable as to how the circumstances may affect you and your family. We, the patient or patients are protected by rights that are put in to place to help reassure us that we will receive the best care possible, without the fear being taken advantage of or our lives taken for granted. Informed consent is defined as a voluntary agreement given by a person or a patients' responsible proxy (for example, a parent) for participation in a study, immunization program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits, and risks. The essential criteria of informed consent are that the subject has both knowledge and comprehension, that consent is freely given without duress or undue influence, and that the right of withdrawal at any time is clearly communicated to the patient. Other aspects of informed consent in the context of epidemiologic and biomedical research, and criteria to be met in obtaining it are specified in International Guidelines for Ethical Review of Epidemiologic Studies (Geneva:...
Words: 916 - Pages: 4
...Author * Diane Paul, M.S., RN National Comprehensive Cancer Network Introduction It is important to understand that informed consent is a process that begins with the recruitment and screening of a subject and the signing of the consent document, continues throughout the subject's involvement in the research, and continues beyond study termination. It includes: * Recruitment efforts encompassing the means of first creating awareness or contact and spanning everything from medical record review to advertisements and other recruitment materials. * Providing specific information and answering questions about the study to subjects in a way that is understandable to them while giving subjects adequate time to consider participation. * Obtaining the voluntary agreement of subjects to take part in the study. While the subject may agree to participate in the study, subjects may withdraw at any time. Part of the ongoing nature of the consent process is verifying the subject's continued interest in participating in the study. * Making plans for the provision of new information to be shared with former subjects, even after the study ends. There is consensus regarding the importance of informed consent. Informed consent is a demonstration of how investigators and those involved in human subjects research show respect to research subjects, and it is...
Words: 3525 - Pages: 15
... potential subjects may be fluent in a language but not literate. Researchers may need to deceive research subjects in order obtain scientifically valid data. Asking subjects to sign consent forms linking them to a study about illegal activities could put them at risk of harm. The federal regulations provide sufficient flexibility to address some of these concerns, particularly for research posing no more than minimal risk of harm. For example, the regulations allow waivers of and alterations in the requirements for the consent and documentation processes. Learning Objectives By the end of this module you should be able to: • Distinguish between consent as a process and the documentation of consent. • Recognize the elements of consent. • Determine when waivers are appropriate. • Identify methods for ensuring comprehension of consent. Overview of Informed Consent Federal regulations require researchers to obtain legally effective informed consent from the subject or the subject's legally authorized representative (LAR). There are two parts to informed consent. The first is the process of providing information to prospective subjects. The second is documentation that the process took place and is a record of the subjects' agreement to take part in the study. In practice, informed consent forms often are used as a...
Words: 2868 - Pages: 12
...Into the Danger Analysis University of the Rockies When I first read the case study " into the danger zone", I thought it was a clean and cut case of the school being held liable for the accident that Lucy Overstreet had when she was diving into the pool during practice. After reading it the second time I realize that the school may not be the only one liable for her accident, but her as well. I say this because she did signed a form stating the risk that can occur from her being on the swim team and she could had left the swim team if she really felt uncomfortable and reported it to the principal what the coach has said to her when she wasn't ready compete in the relay where she had to dive off a starter block. The tort of negligence for this case study may not be easy to prove as one may think when you first read the study. The reason for this is because to prove tort of negligence all 5 elements of negligence has to be proven. The 5 see elements are duty, breach, cause-in-fact, proximate cause, and damages. However I will be looking at how if all the elements can be proven, I will start by looking at duty of the coach. The coach did not do its duty to protect Lucy from being injured at swim practice. The reason I would say this is because Lucy trainers and Lucy herself had told the swim coach that she needed more practice with her diving from the starter block into shallow water. And with this knowledge he did not change her position on the team but encourage to quit...
Words: 1104 - Pages: 5
...Decision-Making Case Study The looming changes in health care are a frequent topic in many meetings with health care providers. Budget cuts are not just a speculation but are a reality. Decision-making to provide quality patient care with less money is a challenge at best. The Informed Decisions Toolbox can assist administrators and managers with evidence-based decisions that will allow patients to receive the quality care they deserve while reducing expenses. The Informed Decisions Toolbox The Informed Decisions Toolbox (IDT) is the result of a research study to aid managers with making evidence-based decisions that improve organizational performance. The IDT has an approach of six steps to decision-making (Rundell, et al, 2007): (1) framing the management question, (2) finding sources of information, (3) assessing the accuracy of the information, (4) assessing the applicability of the information, (5) assessing the actionability of the evidence, and (6) determining if the information is adequate (p. 325). As a facilitator for the use of evidence-based research in decision-making, the IDT assists decision-makers with estimating how operational and strategic decisions will have an effect on the organization. Evidence-based decision-making is not new to the health care industry. Clinicians have incorporated evidence-based research for years when making patient treatment determination. The use of evidence-based research for decision-making in other realms of healthcare...
Words: 1573 - Pages: 7
...INVESTIGATOR 3. PAYMENT 4. RECORDKEEPING, REPORTING, ACCESS 5. PROPRIETARY INFORMATION AND CONFIDENTIALITY 6. STUDY DATA 7. PUBLICATION AND STUDY REGISTRATION 8. INTELLECTUAL PROPERTY 9. TERM AND TERMINATION 10. INDEMNIFICATION 11. PATIENT CARE COSTS 12. NOTICES 13. INDEPENDENT CONTRACTORS AND ASSIGNMENT 14. DISCLOSURE OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION 15. DUTY TO UPDATE REGARDING SAFETY INFORMATION 16. USE OF OTHER PARTIES’ NAMES 17. LIMITATION OF LIABILITY 18. WAIVER AND SEVERABILITY 19. CONTINUING OBLIGATION 20. FORCE MAJEURE 21. GOVERNING LAW 22. EXPORT CONTROLS 23. COUNTERPARTS 24. ENTIRE AGREEMENT; AMENDMENT THE JOHNS HOPKINS UNIVERSITY MODEL CLINICAL TRIAL AGREEMENT This Agreement (the “Agreement”) is entered into as of this ______ day of ______, 20____ (the “Effective Date”) by and between: THE JOHNS HOPKINS UNIVERSITY, having a School of Medicine with an Office of Research Administration located at 733 North Broadway, Suite 117, Baltimore, Maryland, 21205 (the “Institution”), employer of ________________ (the “Investigator”), and [SPONSOR NAME IN ALLCAPS], a corporation organized under the laws of the State of _____________, located at ________________ (the “Sponsor”). WHEREAS, Sponsor desires Institution to conduct a clinical study, and such study is of mutual interest and benefit to the Institution and Sponsor. NOW, THEREFORE, in consideration of the premises and...
Words: 3786 - Pages: 16
...care reform. I will be talking about how the governor thinks by” issuing top-down mandates on a break-neck timetable is a surefire way to make things worse”. The health care reform legislation currently being considered not only poses a serious threat to patients and providers, but will also cost Texas taxpayers tens of billions of dollars. I will be explaining how the governor feels that President Obama’s plan will cause harm to the health care system,” by increasing taxes and escalate medical price inflation and add more than $285 billion to the deficit over the next 10 years”. “Gov. Perry: Federal Health Care Proposals to Cost Texans Tens of Billions of Dollars Tuesday, August 18, 2009 • Austin, Texas • Press Release Share” “Gov. Rick Perry today emphasized the importance of state developed health care reform rather than the costly, expansive, one-size-fits-all mandates being considered by the federal government. The governor spoke at a press conference announcing the results of a study about federal health care proposals conducted by the Texas Public Policy Foundation (TPPF)”. “It’s clear Washington has no interest in allowing states to develop their own tailored solutions to problems that affect their citizens,” “Gov. Perry said”. “Instead we have a federal government bearing down on the states, preparing to take greater control through mandates and trampling innovation through runaway costs. The health care reform legislation currently being considered not only poses...
Words: 1364 - Pages: 6
...Social Work: Juvenile Delinquency In the last twenty years, juvenile crime is at its lowest point. It has decreased 36% since 1996 (Office of Juvenile Justice and Delinquency Prevention). With this change in crime rate, it can be assumed that the prevention of juvenile delinquency has been a great asset to our country, and leads into the profession of social workers role in juvenile delinquency. An overview of this field requires a social worker to be knowledgeable with criminal law, principles and education that can be gained from experience, familiarity with laws and practices, and awareness of environmental contributors. The social worker must be prepared to work in a variety of settings, and with other professions that contribute to cases. Overview of Social Problem The Social Work Dictionary states that juvenile delinquency is seen as a person under the age of 18 (some jurisdictions go by 21) that have been involved in criminal activity (juvenile delinquency, 2003). In 2002, juvenile delinquency was at its lowest point in the last two decades. Despite the statistics, most people believe that juvenile crime continues to rise. The media plays a great part in this problem because when a violent crime involves young offenders, the media has excessive coverage on situation. The average age of delinquents continue to be younger and younger. Even though juvenile crime has decreased, but serious violent crime rate for boys and girls are excessively high (McWhirter et al, 2007)...
Words: 3126 - Pages: 13
...past data indicates it has not always been so. The Institute of Medicine determined in the late 1990’s that 44,000 to 98,000 patients die from medical mistakes each year (Wachter, 2008). This tremendous number of deaths places medical care mishaps between the fifth and eighth leading causes of deaths in the United States (Kizer, 2001). In 2002, The Joint Commission established National Patient Safety Goals (NPSG) to help accredited organizations with patient safety in specific areas. An advisory group comprised of nurses, physicians, pharmacists, risk managers, clinical engineers, and others with appropriate experience advises The Joint Commission on how to address emerging patient safety issues. This group also periodically develops and updates the goals. The goals are grouped into broad categories and for 2011-2012, cover such categories as patient identification, health care-associated infections, improving communication, medication safety, reducing falls, and risk assessment. A discussion of selected elements underlying the current NPSG such as hand washing techniques, training, and lack of communication between healthcare personnel that can lead to medication errors, to falls, and even death, plus other related factors such as staffing shortages, problems with using outdated equipment, considerations in using the electronic medical records, and compliance with statutes provide insight into the challenges faced by today’s healthcare institutions and providers. Healthcare...
Words: 5259 - Pages: 22
...THIS AGREEMENT is made and entered into this _____ day of July, 2009, by and between ^, a resident of ^, and ^, a resident of ^, who shall be collectively known herein as "the parties". The agreement is also known as a "Premarital agreement". WITNESSETH: WHEREAS, the parties are presently unmarried and intend to be married to each other within the next year and, in anticipation of such marriage, the parties desire to fix and determine various financial relationships that will apply during their marriage and upon the termination of their marriage whether by death, divorce or otherwise; WHEREAS, information about each of the parties' assets, liabilities and approximate current income has been exchanged prior to entering into this agreement and summations of said information for each party is contained herein as Schedule A; WHEREAS, each party has had the opportunity to fully examine the financial disclosures of the other party as summarized in Schedule A; WHEREAS, neither party has consulted with an attorney concerning this agreement prior to entering into it; WHEREAS, each party enters into this agreement freely and under no duress or undue influence upon his or her decision to sign. The premises being considered, upon consideration of the mutual promises hereinafter set forth and for other good and valuable considerations, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows: I. Effective Date of Agreement. This Agreement...
Words: 2478 - Pages: 10
...Admissions Procedures Requirements At MIT, a regular graduate student is one who is registered for a program of advanced study and research leading to a post-baccalaureate degree. A regular graduate student may concurrently hold an appointment as a research assistant, teaching assistant, or instructor. To be admitted as a regular graduate student, an applicant must have earned a bachelor’s degree or its equivalent from a college, university, or technical school of acceptable standing. Students in their final year of undergraduate study may be admitted on the condition that their bachelor’s degrees are awarded before they enroll at MIT. Applicants are evaluated by the individual department in which they intend to register on the basis of their prior performance and professional promise, as evidenced by their academic records, letters of evaluation from individuals familiar with their capabilities, and any other pertinent data they submit. While high academic achievement does not guarantee admission, MIT expects such achievement or other persuasive evidence of professional promise. Specific admission requirements vary by department; please consult the catalogue and department or program website for the requirements of individual departments. In general, most departments require significant work in mathematics and the physical sciences in addition to preparation in a specific field of interest, but some admit students with as little as one year each of college-level mathematics...
Words: 9908 - Pages: 40
...Admissions Procedures Requirements At MIT, a regular graduate student is one who is registered for a program of advanced study and research leading to a post-baccalaureate degree. A regular graduate student may concurrently hold an appointment as a research assistant, teaching assistant, or instructor. To be admitted as a regular graduate student, an applicant must have earned a bachelor’s degree or its equivalent from a college, university, or technical school of acceptable standing. Students in their final year of undergraduate study may be admitted on the condition that their bachelor’s degrees are awarded before they enroll at MIT. Applicants are evaluated by the individual department in which they intend to register on the basis of their prior performance and professional promise, as evidenced by their academic records, letters of evaluation from individuals familiar with their capabilities, and any other pertinent data they submit. While high academic achievement does not guarantee admission, MIT expects such achievement or other persuasive evidence of professional promise. Specific admission requirements vary by department; please consult the catalogue and department or program website for the requirements of individual departments. In general, most departments require significant work in mathematics and the physical sciences in addition to preparation in a specific field of interest, but some admit students with as little as one year each of college-level mathematics...
Words: 10615 - Pages: 43
...Lesson 3 – Informed Consent, Substitute Decision-Making, and the Family Centered Approach * It should be noted that a choice might properly require only low/ minimal competence, even though its expected risks exceed its expected benefits or it is more generally a high-risk treatment, because all other available alternatives have substantially worse risk/benefit ratios. * Thus, according to the concept of competence endorsed here, a particular individual’s decision-making capacity at a given time may be sufficient for making a decision to refuse a diagnostic procedure when forgoing the procedure does not carry a significant risk, although it would not necessarily be sufficient for refusing a surgical procedure that would correct a life-threatening condition * The greater the risk relative to other alternatives—where risk is a function of the severity of the expected harm and the probability of its occurrence—the greater the level of communication, understanding, and reasoning skills required for competence to make that decision. * It is not always true, however, that if a person is competent to make one decision, then he or she is competent to make another decision so long as it involves equal risk. * Even if the risk is the same, one decision may be more complex, and hence require a higher level of capacity for understanding options and reasoning about consequences. * The evaluation of the patient’s decision-making will seek to assess how well...
Words: 3335 - Pages: 14
...Revised 12/2/2014 FIRE DEPARTMENT ● CITY OF NEW YORK STUDY MATERIAL FOR THE CERTIFICATE OF FITNESS EXAMINATION FOR F-03 INDOOR PLACE OF ASSEMBLY SAFETY PERSONNEL (Premises related) © 08/2012 New York City Fire Department - All rights reserved ® TABLE OF CONTENT NOTICE OF EXAMINATION ....................................................................................... I STUDY MATERIAL AND TEST DECRIPTION ..................................................VII INTRODUCTION ............................................................................................................ 1 Requirements........................................................................................................................ 1 Definition................................................................................................................................ 3 Disasters at public gatherings ....................................................................................... 4 Proper responses, different results ............................................................................. 7 PART I. INDOOR PLACE OF ASSEMBLY SAFETY PERSONNEL ................ 8 1. THE DUTIES OF PLACE OF ASSEMBLY SAFETY PERSONNEL........... 8 1.1 Fire safety and evacuation plan ...................................................................... 8 1.2 Pre-event inspection..........................................................................................
Words: 11241 - Pages: 45
